A Motion Exergaming Approach to Promote Self-Managing Fatigue and Pain after Head and Neck Cancer Treatment

运动游戏方法可促进头颈癌治疗后自我管理疲劳和疼痛

• 批准号: 10618083
• 负责人: Hsiao-Lan Wang
• 金额: $ 59.3万
• 依托单位: UNIVERSITY OF ALABAMA AT BIRMINGHAM
• 依托单位国家: 美国
• 财政年份: 2019
• 资助国家: 美国
• 起止时间: 2019-12-13 至 2025-11-30
• 项目状态: 未结题
• 来源: https://reporter.nih.gov/project-details/10618083
• 关键词: Address; Adverse event; Aftercare; Age; Articular Range of Motion; Behavior; Behavioral; Cancer Patient; Cancer Survivor; Cancer Survivorship; Chronic Disease; Clinical; Competence; Control Groups; Data; Education; Eligibility Determination; Enrollment; Enteral Feeding; Equipment; Exercise; Fatigue; Future; Goals; Guidelines; Head and Neck Cancer; Health; Home; Home visitation; Impairment; Individual; Intervention; Literature; Long-Term Effects; Malignant Neoplasms; Mediating; Mediation; Modeling; Motion; Musculoskeletal Pain; National Comprehensive Cancer Network; Operative Surgical Procedures; Outcome; Pain; Pain management; Participant; Patients; Performance; Phase; Physical activity; Pilot Projects; Publishing; Quality of life; Radiation; Recommendation; Reporting; Research Design; Science; Self Efficacy; Self Management; Series; Skeletal Muscle; Stimulus; Sum; Symptoms; Testing; Time; Tissues; Tracheostomy procedure; Treatment-Related Cancer; Upper Extremity; Walking; acceptability and feasibility; active method; attentional control; base; cancer survival; cancer therapy; chemoradiation; design; evidence base; exercise intervention; exergame; fitness; functional adaptation; functional status; grasp; group intervention; head and neck cancer patient; health belief; improved; innovation; pain score; physical symptom; primary outcome; programs; public health relevance; response; secondary outcome; sex; side effect; social cognitive theory; survivorship; symptom self management; telehealth; treatment duration; visual feedback

Project Summary/Abstract Among head and neck cancer (HNC) patients, 92% report fatigue and 73% have pain. A 10% increase in fatigue or pain is associated with a 10-25% reduction in HNC survival. During the critical transition period from the end of active treatment to 3 months post-treatment (during which patients begin symptom self- management), untreated physical symptoms negatively impact functional status (ADL) and quality of life (QOL). Fatigue and musculoskeletal pain (related to tissue damage from surgery and radiation) are known to improve in response to physical activity (PA). However, 51% of HNC survivors rarely engage in any type of PA because of complicated PA barriers: impaired fitness, severe physical symptoms, and poor PA health beliefs. A critical gap in our science is that no home-based behavioral PA intervention effectively addresses these PA barriers in HNC patients. To address this gap, our overall objective is to test an intervention to overcome these PA barriers for HNC patients during the critical transition period to self-management. PAfitME, a personalized Physical Activity intervention with fitness graded Motion Exergames, is a telehealth program built on Social Cognitive Theory and the exercise principal of adaptation. PAfitME is personalized to the HNC patient's PA barriers. PAfitME, delivered via a tested mix of FaceTime calls and home visits, uses commercially available exergaming platforms (Wii Fit and Xbox Kinect). Our pilot study generated impressive within-group effect sizes for fatigue, pain, and ADL (d≥0.9). The feasibility and acceptability of PAfitME were also strong in patients with several physical limitations. Attendance (98%) and attrition (20%) were much better than previous HNC studies without adverse events. We propose the following specific aims: (1) When compared to an attention control group, determine the effect of PAfitME on fatigue and musculoskeletal pain at week 6, when controlling for age and sex; (2) when compared to an attention control group, determine the effect of PAfitME on functional status and QOL at week 6, when controlling for age and sex; and (3) explore if PA self-efficacy, PA enjoyment, and exergame minutes mediate the effect of PAfitME on fatigue and musculoskeletal pain. This study will evaluate 150 post-treatment (radiation or chemoradiation) HNC patients in an RCT with an attention control. For 6 weeks, the experimental (PAfitME) group will receive the PAfitME intervention, and the attention control group will receive NCI-based survivorship education and exergame equipment (Wii Fit or Xbox Kinect without PAfitME). For Aims 1 and 2, using an ITT framework, we will fit a series of linear mixed effects models with each of the outcome variables. For Aim 3, we will conduct our exploratory analyses in ml_mediation (STATA 15), which will compute direct and indirect effects for multi-level data. This study aligns with the NCI Cancer Moonshot goal to minimize cancer treatment-associated side effects and the key recommendation in the National Comprehensive Cancer Network Clinical Guidelines of the need for evidence-based non- pharmacological fatigue/pain treatments (National Priority).

项目摘要/摘要 在头颈癌（HNC）患者中，有92％的人报告疲劳和73％的患者患有疼痛。增长10％ 疲劳或疼痛与HNC存活率降低10-25％有关。在关键的过渡期 治疗后3个月的主动治疗结束（在此期间，患者开始症状自我 管理），未经治疗的身体症状对功能状况（ADL）和生活质量产生负面影响 （QOL）。已知疲劳和肌肉骨骼疼痛（与手术和辐射的组织损伤有关）已知 响应体育锻炼（PA）。但是，有51％的HNC存活很少参与任何类型的PA 由于PA的复杂障碍：健身受损，严重的身体症状和PA健康信念差。 我们科学中的一个关键差距是，没有基于家庭的行为PA干预有效地解决这些PA HNC患者的障碍。为了解决这一差距，我们的总体目标是测试一项干预措施以克服这些差距 在关键过渡期间，HNC患者的PA障碍。 Pafitme，个性化 体育活动干预与健身等级运动Exergames，是一个基于社会的远程医疗计划 认知理论和适应的运动原理。 Pafitme是个性化的，是HNC患者的PA 障碍。 Pafitme是通过经过测试的FaceTime电话和家庭访问的混合物交付的，它使用了市售的 Exergaming平台（Wii Fit和Xbox Kinect）。我们的试点研究产生了令人印象深刻的小组内效应大小 对于疲劳，疼痛和ADL（D≥0.9）。 Pafitme的可行性和可接受性在患者中也很强 几个物理局限性。出勤率（98％）和损耗（20％）比以前的HNC研究好得多 没有不利事件。我们提出以下特定目的：（1）与注意力控制相比 小组，确定Pafitme在控制年龄时在第6周对疲劳和肌肉骨骼疼痛的影响 和性； （2）与注意力控制组相比，确定PAFITME对功能状态的影响 和第6周的QoL，在控制年龄和性别时； （3）探索自我效能感，享受和 Exergame分钟介导Pafitme对疲劳和肌肉骨骼疼痛的影响。这项研究将评估 150个具有注意力控制的RCT的HNC患者的治疗后（放射线或化学放疗）患者。 6 几周，实验（Pafitme）组将接受PAFITME干预，注意控制组 将获得基于NCI的生存教育和Exergame设备（Wii Fit或Xbox Kinect无需 pafitme）。对于目标1和2，使用ITT框架，我们将与一系列线性混合效应模型一起使用 每个结果变量。对于AIM 3，我们将在ML_Mediation（Stata）进行探索性分析 15），这将计算多层数据的直接和间接效果。这项研究与NCI癌保持一致 月球的目标是最大程度地减少癌症治疗相关的副作用，并在 国家综合癌症网络网络临床指南，需要基于证据的非 - 药理疲劳/疼痛治疗（国家优先）。